CAJ | 학술논문

背景：为提高钛材料的抗菌性及生物相容性，前期研究制备了铜钛合金材料。目的：参照GB/T16886-ISO10993所规定的原则和实验方法对铜钛合金进行较为全面、系统的生物相容性评价。方法：根据预实验结果，选择含铜量10%的铜钛合金材料，通过口腔黏膜刺激实验、皮肤刺激实验、短期全身毒性实验、溶血实验、血浆复钙时间实验、凝血酶原时间实验及动态凝血实验验证铜钛合金的生物相容性。结果与结论：铜钛合金材料无口腔黏膜刺激性、无短期全身毒性、无溶血性、无皮肤致敏反应，具有良好的血液相容性。
배경：위제고태재료적항균성급생물상용성，전기연구제비료동태합금재료。목적：삼조GB/T16886-ISO10993소규정적원칙화실험방법대동태합금진행교위전면、계통적생물상용성평개。방법：근거예실험결과，선택함동량10%적동태합금재료，통과구강점막자격실험、피부자격실험、단기전신독성실험、용혈실험、혈장복개시간실험、응혈매원시간실험급동태응혈실험험증동태합금적생물상용성。결과여결론：동태합금재료무구강점막자격성、무단기전신독성、무용혈성、무피부치민반응，구유량호적혈액상용성。
BACKGROUND:Copper-titanium aloy has been fabricated in previous studies to improve the antibacterial property and biocompatibility of titanium materials. OBJECTIVE:With reference to the principle and experimental method specified by GB/T16886-ISO10993, to fuly and systematicaly assess the biocompatibility of copper-titanium aloy. METHODS:Based on the pre-experimental results, titanium aloy containing 10% copper was selected and subjected to oral mucosa stimulation experiment, skin stimulation test, acute systemic toxicity test, hemolytic test, prothrombin time test and dynamic coagulation test for biocompatibility evaluation. RESULTS AND CONCLUSION:The copper-titanium aloy has no oral mucous membrane irritation, no short-term systemic toxicity, no skin sensitization, and no hemolysis, indicating it has a good biocompatibility.